MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE VIABAHN ENDOPROSTHESIS - 3; NIP

Model Number VBH101002A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/25/2019

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing records indicated the device met pre-release specifications.Investigation is ongoing.

Event Description

The following was reported to gore: on (b)(6) 2019 the patient presented with thrombus in an aneurysm found in the left axillary artery.The patient showed little to no flow in the lower left upper extremity (hand) prior to the procedure.A declotting procedure was performed prior to treating the lesion.The physician made the decision to advance a 10mm x 10 cm gore® viabahn® endoprosthesis on a 0.035" amplatz guidewire with no introducer sheath.The device would not cross the lesion and was removed.The physician then inserted an 11fr pinnacle destination sheath and elected to use the same device.The device was then advanced across the lesion and successfully deployed.However, during deployment, the deployment line got hung up on the device.The physician cut the deployment knob and removed the catheter.The decision was made to insert the deployment line through a 5fr x 45cm terumo sheath and advance the sheath to the device.While pushing the sheath and pulling the deployment line the physician was successful in the detaching the deployment line from the device.An additional 10mm x 5cm gore® viabahn® endoprosthesis device was successfully deployed to complete the procedure.The patient tolerated the procedure and is doing well.

Manufacturer Narrative

The device was returned to w.L.Gore & associates for examination.The following observations were made: the deployment knob, deployment line, delivery catheter, and guidewire were returned.The guidewire was not evaluated as it is not a gore product.The deployment line appeared to be broken.The deployment knob had approximately.1cm of deployment line coming from the end.The remainder of deployment line measured 195.4cm and was tangled within the guidewire.The remainder of the device appeared unremarkable.Based on the device examination performed, no manufacturing anomalies were identified to which the event could be definitively attributed.

Manufacturer Narrative

A2, date of birth - (b)(6) 1959.H6, conclusion code 1 - 4315.Ifu warning statements: special care should be taken to ensure that the appropriate size endoprosthesis, compatible sheath and guidewire are selected prior to introduction.Native vessel dimensions must be accurately measured, not estimated.Do not withdraw the gore® viabahn® endoprosthesis back into the introducer sheath once the endoprosthesis is fully introduced.Withdrawing the gore® viabahn® endoprosthesis back into the sheath can cause damage to the endoprosthesis, premature deployment, deployment failure, and / or catheter separation.If removal prior to deployment is necessary, withdraw the gore® viabahn® endoprosthesis to a position close to but not into the introducer sheath.Both the gore® viabahn® endoprosthesis and introducer sheath can then be removed in tandem.After removal, do not reuse the gore® viabahn® endoprosthesis or introducer sheath.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9558644
• MDR Text Key: 197653283
• Report Number: 2017233-2020-00012
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00733132623228
• UDI-Public: 00733132623228
• Combination Product (y/n): N
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 03/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/11/2022
• Device Model Number: VBH101002A
• Device Catalogue Number: VBH101002A
• Device Lot Number: 20466901
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/07/2020
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/23/2020; 03/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR